In a show­down with As­traZeneca, Pfiz­er posts sol­id — and very fa­mil­iar — PhI­II breast can­cer da­ta for ta­la­zoparib

Jen­nifer Lit­ton, MD An­der­son Can­cer Cen­ter

Pfiz­er $PFE came through with pos­i­tive num­bers for its Phase III study of its PARP in­hibitor ta­la­zoparib in ad­vanced breast can­cer — lin­ing up right along­side As­traZeneca’s $AZN lead­ing ri­val Lyn­parza. And the re­sults po­si­tion Pfiz­er to join the PARP line­up as the fourth play­er to toe up to the mar­ket thresh­old — though maybe not in the lead po­si­tion it was promised when the phar­ma gi­ant bought the drug last year.

An­a­lysts have been wait­ing to see how Pfiz­er’s drug, bagged in the $14 bil­lion ac­qui­si­tion of Medi­va­tion, will fare rel­a­tive to the com­pe­ti­tion. It’s a wide­ly frowned on ap­proach by the ex­perts, but mar­ket an­a­lysts love to match up da­ta from two dif­fer­ent stud­ies of the same dis­ease, of­fer­ing caveats on what could be im­por­tant dis­tinc­tions in tri­al de­signs, pa­tient pop­u­la­tions and end­points.

In this case, which begs for a com­par­i­son, the num­bers are close enough to Lyn­parza’s read­out ear­li­er in the year that it will like­ly em­pha­size just how com­pa­ra­ble these ther­a­pies can be, in­clud­ing the com­pe­ti­tion at Tesaro $TSRO (Ze­ju­la) and Clo­vis $CLVS (Rubra­ca).

Pfiz­er’s re­searchers con­clud­ed that there was a 45.8% re­duc­tion in the risk of dis­ease pro­gres­sion in the EM­BRA­CA study, which re­cruit­ed women with HER2-neg­a­tive breast can­cer with germline BR­CA mu­ta­tion. Me­di­an PFS was 8.6 months, com­pared to 5.6 months in the con­trol arm.

The over­all re­sponse rate was 62.6% in the drug arm com­pared with on­ly 27.2% in the con­trol. There were al­so 12 com­plete re­spons­es — no vis­i­ble signs of the dis­ease — for ta­la­zoparib, com­pared to none in con­trol.

“Most no­table for this study was not on­ly the im­prove­ment to date of PFS, but the time to clin­i­cal de­te­ri­o­ra­tion, which was 24.3 months for pa­tients on ta­la­zoparib, ver­sus 6.3 months for those on stan­dard-of-care chemother­a­py,” MD An­der­son’s Jen­nifer Lit­ton not­ed.

Com­pare that to Lyn­parza’s 42% re­duc­tion in the risk of pro­gres­sion, a 7-month ver­sus 4.2-month PFS — or a gap of 2.8 months ver­sus 3 months for ta­la­zoparib — and a 59.9% ta­la­zoparib vs 28.8% chemo ORR.

Both stud­ies com­pared their drug against stan­dard of care chemo.

For­mer Medi­va­tion CEO David Hung sold this drug hard in dri­ving the deal to sell his com­pa­ny to Pfiz­er for $14 bil­lion last year, claim­ing it was clear­ly su­pe­ri­or to every­thing out there. That would be an even hard­er sales job to­day, with the late-stage da­ta on dis­play.

Michael Schmidt didn’t see much day­light be­tween what Pfiz­er and As­traZeneca have on of­fer, and he con­sid­ers that a plus for Clo­vis.

Ta­la­zoparib was pre­vi­ous­ly tout­ed as po­ten­tial “best-in-class” PARP in­hibitor and most po­tent “PARP trap­per”. That said, at least based on the pre­lim­i­nary da­ta dis­closed in PFE’s (MP)press-re­lease this morn­ing, re­sults in breast can­cer look rather sim­i­lar to AZN’s (MP) OLYMPIAD tri­al re­sults of Lyn­parza which were pre­sent­ed ear­li­er this year at AS­CO. We think this bodes well for CLVS. Pos­i­tive EM­BRA­CA da­ta pro­vides ad­dl. val­i­da­tion for PARPs in breast can­cer, how­ev­er po­ten­tial lack of mean­ing­ful clin­i­cal dif­fer­en­ti­a­tion and hence a cred­i­ble com­pet­i­tive threat by ta­la­zoparib should read through pos­i­tive­ly for CLVS.

Tesaro launched the Phase III BRA­VO study to see how their drug per­formed in a sim­i­lar breast can­cer pop­u­la­tion, but not­ed back in March that it couldn’t serve as a reg­is­tra­tion study af­ter pa­tients bowed out, pre­fer­ring to get a mar­ket­ed PARP rather than chemo. The biotech went on to say that it is study­ing its drug in com­bi­na­tion with a check­point ther­a­py in breast can­cer.

Im­age: Shut­ter­stock

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Af­ter the field left her be­hind, a sci­en­tist-turned-in­vestor gets her first R&D job; Nous­com finds new lead­er­ship for its can­cer vac­cines

Before she boarded the plane, Cristina Ghenoiu spent most school day afternoons at Bucharest’s National Museum of Natural History, studying endangered animals Romanian scientists had brought back from around the country, or the world. The communist government sponsored a wide range of programs for kids so both parents could work. Her sister danced; Ghenoiu fell in love with biology.

And she was good, at least good enough to win several national awards and then, at 15, a spot as Romania’s representative to an international school in Canada that accepted about one person per country.

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Brian Stuglik (file photo)

Turn­ing fo­cus to clin­i­cal work, Ve­rastem ax­es 31 jobs, scales back can­cer drug pro­mo­tion af­ter dis­ap­point­ing sales

Months after taking the helm at Verastem Oncology, Brian Stuglik has a plan to take the biotech in a “new strategic direction” — but not before some layoffs.

Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs. Alongside some other cost-saving measures, Verastem expects to cut expenses down by $70 million to $80 million per year.

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Olivier Brandicourt (AP Images)

Ex-Sanofi chief Olivi­er Brandi­court, cur­rent Black­stone ad­vi­sor, jumps on Al­ny­lam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

Sage con­firms sus­pen­sion of 2 de­pres­sion tri­als af­ter PhI­II flop; Es­pe­ri­on fol­lows up maid­en ap­proval with com­bo OK

→ In the wake of a flop in the crucial Phase III MOUNTAIN study, Sage Therapeutics confirmed in its quarterly update that it’s suspended enrollment in two other pivotal trials for the oral depression drug SAGE-217 (or zuranolone) as it awaits guidance from the FDA. While REDWOOD (measuring relapse) and RAINFOREST (for patients with both major depressive disorder and insomnia) are on hold pending amendments, though, the open-label SHORELINE has completed enrollment. CEO Jeff Jonas remained tight-lipped about what specific tweaks they are considering for the program, reiterating only there have been issues with compliance and room for a higher dose.

Dan O'Day (AP Images)

UP­DAT­ED: A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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